This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well tolerated and immunogenic.
This study will test the safety, tolerability, and immunogenicity of the DNA vaccine, INO-4212 and its components INO-4201 and INO-4202 in healthy volunteers. INO-4201 contains the DNA sequence that codes for past Ebola Zaire virus outbreak strains, and INO-4202 contains the DNA sequence that codes for the current Ebola virus outbreak strain. When given together, the DNA vaccine is called INO-4212 and contains the DNA sequence of both the previous and the current outbreak strain. Another ingredient called INO-9012 which contains the DNA sequence for interleukin-12, will be given in a subset of subjects to help boost the body's immune response when given with the vaccine. Following administration of vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move more DNA into cells more efficiently. The study will evaluate whether INO-4212 and its components may be able to generate protective immunity against Ebola Zaire, evaluate the relative ability of IM versus ID administration to elicit immune responses and evaluate whether vaccine administered with INO-9012 can generate greater immune responses. The Ebola vaccine under study will be tested in approximately 240 healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
QPS MRA
Miami, Florida, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Safety Assessment (Composite of multiple measures: adverse events, pain (VAS), lab abnormalities, changes in vital signs)
Composite of multiple measures consist of: * Frequency and severity of all adverse events * Local pain immediately and at 5 and 10 minutes after Study Treatment/EP using a visual analog scale from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" * Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP * Frequency and severity of laboratory abnormalities * Changes in vital signs (blood pressure, heart rate, respiratory rate, temperature)
Time frame: Screening through up to 60 weeks following the first dose
Immunology Assessment
Composite outcome measure consisting of multiple measures, including: * Breadth and magnitude of antigen specific ELISA * Breadth and magnitude of neutralizing antibodies * Breadth and magnitude of antigen specific cellular immune responses as determined by * Interferon-gamma (IFN-γ) ELISpot * Intracellular Cytokine Staining (CTL phenotype, Lytic granule loading, Granzyme B killing of target cells)
Time frame: Screening and at select points up to 60 weeks following the first dose
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INO-4212 delivered IM followed by Electroporation
INO-4212 + INO-9012 delivered IM followed by Electroporation
INO-4201 + INO-9012 delivered ID followed by Electroporation